MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPO GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 8040

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

It was reported that guidewire perforated the shaft.The target lesion was located in the left superior pulmonary vein.A 6f expo guide catheter and an amplatz super stiff guidewire were selected for use.The amplatz super stiff was used for the transseptal sheath to cross the left atrium.During the procedure with the expo, the transseptal dilator was removed and the expo pigtail was advanced over the wire midway up.Once the pigtail was torqued at the tip of the wire, it was seen that the wire had sheared into two parts.One part of the wire was protruding from the sidewall of the pigtail and the other had tilt through the distal tip.The wire and the catheter were removed.The procedure was completed with another of same device.No patient complications were reported.

• Brand Name: EXPO GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): FLEXTRONICS INTERNATIONL EUROPE B V; noblestraat 10 14; oostrum lb 5807 GA; NL 5807 GA
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9825742
• MDR Text Key: 183178374
• Report Number: 2134265-2020-02916
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729169475
• UDI-Public: 08714729169475
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2021
• Device Model Number: 8040
• Device Catalogue Number: 8040
• Device Lot Number: 0060216217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1